Effect of Ambient Temperature Variations on Positivity of Manual Fecal Immunochemical Tests.

Abstract

INTRODUCTION: In the United States, many fecal occult blood tests are mailed by patients to a laboratory for analysis. Hemoglobin is not stable in feces and can be affected by the heat. Effects of season and ambient temperature on fecal immunochemical tests (FITs) have demonstrated a decrease in positivity rates during the hottest season. OBJECTIVE: To investigate the potential effect of the average of 4-day ambient maximum temperature variations on the positivity of a single sample, one-time Clinical Laboratory Improvement Amendments (CLIA)-waived FIT. SETTING: Midwestern tertiary care hospital. METHODS: Individuals scheduled for a colonoscopy were invited to complete a qualitative FIT prior to their colonoscopy in 2010 and 2011. FITs were read as positive or negative. RESULTS: Valid FITs were received from 1026 individuals over 25 months. The positivity rate was 10.9%. The mean 4-day average of daily maximum ambient temperatures was calculated including the day of receipt for each sample. Fahrenheit temperatures ranged from 16.0 to 96.8. Based on the odds ratio of 1.04 with a confidence interval of 0.94 to 1.14 for a 10°F increase in temperature, there was no statistically significant evidence of an effect of the preceding maximum average 4-day ambient temperature on FIT positivity. CONCLUSION: No evidence was found that ambient temperature had an effect on positivity rate over a 25-month period using 4 different qualitative FIT products. Further analysis on effect of ambient temperatures is warranted for the automated FITs and CLIA-waived FITs, including liquid-vial and dry-slide FITs. Primary care providers need to be aware of potential adverse effects of FITs.